The company announced that the U.S. FDA lifted a clinical hold on its Phase 3 trial of ATTR-CM treatment drug.
Shares of Intellia Therapeutics (NTLA) surged nearly 10% in pre-market trading on Monday after the company announced that the U.S. Food and Drug Administration (FDA) lifted a clinical hold on its Phase 3 MAGNITUDE trial of nexiguran ziclumeran (nex-z) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a potentially fatal heart condition.
The hold was placed in October 2025 after a patient experienced severe liver-related side effects. The company has now agreed with the FDA on new safety measures, including closer monitoring of liver function, short-term steroid treatment if needed, and stricter patient screening. Some patients with liver issues or serious heart instability will be excluded.
MAGNITUDE is set to study about 1,200 patients to evaluate the safety and effectiveness of a single dose of nex-z compared to placebo.
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